FDA recently shared information regarding a number of ongoing FDA Food Safety Modernization Act (FSMA) implementation issues. This post summarizes updates and developments regarding the following matters:

1. The written assurance requirements under several FSMA regulations;
2. Industry concerns regarding the Intentional Adulteration regulation;
3. Regulation of human food by-products for use as animal food when these materials are further processed to facilitate storage and distribution;
4. Various initiatives regarding implementation of the Produce Safety rule; and
5. Compliance with the Sanitary Food Transportation rule.

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On December 1, 2017, the United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS or the agency) issued its Fiscal Year 2018 Annual Plan.  The Annual Plan, which is directly aligned with the agency’s 2017 – 2021 Strategic Plan, outlines the ways FSIS plans to achieve its strategic goals over the next fiscal year. It serves as an operational guide for FSIS, where the agency explains the progression of activities from the key milestones the agency achieved in FY 2017, outlines what it plans to achieve in FY 2018 and why, and describes how it will assess progress by using Strategic and Annual Plan measures and targets.

Overall, the agency anticipates focusing on prevention of product contamination and foodborne illness, modernizing systems and approaches, and streamlining to enhance business. Continuing priorities for FY 2018 include further implementation of the New Poultry Inspection System (NPIS) and Siluriformes fish inspection, effectively using Public Health Risk Evaluations (PHREs) and pathogen reduction performance standards for Salmonella and Campylobacter in poultry, and modernizing swine and egg products inspection systems. The agency plans to continue increasing use of whole genome sequencing, further develop key informational tools and resources for inspection personnel, and work with public health partners to prevent Listeria monocytogenes in retail  delicatessens. The agency will also encourage industry continued adoption of food defense and humane handling practices, and consumer adoption of safe food-handling practices.

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The Proposition 65 Interim BPA warning regulation that allows companies to rely on a generic warning posted in California retail establishments will sunset on December 30, 2017. Food and beverage companies that have BPA containing packages in California and that have been relying on the interim BPA warning regulation for compliance should reassess their Proposition 65 warning obligations prior to December 31, 2017.

By way of brief background, effective May 11, 2016, OEHHA started requiring warnings for consumer products containing BPA under the Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65 or Prop 65). Due to the high percentage of the canned and bottled food and beverages that were packaged with BPA-containing materials in California at that time, OEHHA adopted an emergency regulation that allowed the temporary use of a standard point-of-sale warning message (e.g., posting of warnings at checkout stands in retail stores) for BPA. In July 2016, OEHHA proposed an interim rule that essentially extended the temporary regulation through December 30, 2017. The interim regulation also required food companies that exercised this option to provide OEHHA with a list of all food products in which BPA was intentionally used in the manufacture of the can lining or jar or bottle seals.

As of today, there are a total of over 23,000 entries of canned or bottled food products listed in the publicly-accessible OEHHA database for products packaged with BPA-containing materials. The sheer number of listed products in the database suggests that many food and beverage companies have been relying on the interim BPA warning regulation for compliance. On December 31, 2017, those food and beverage companies with products listed in the OEHHA database that have not phased out the use of BPA in their packaging should assess their options for compliance with Proposition 65. Companies should consult with legal counsel when assessing whether they will have an obligation to provide a Prop 65 warning and if so, the type of warning that should be required.

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After three years of negotiations, the European Union is nearing the end of a long process to simplify and harmonize the rules for organic food production and the labeling of organic products. Council Regulation (EC) 834/3007 currently defines the minimum standards for organic products that are produced, manufactured, imported into, sold or traded within the EU, as well as the national inspection and certification systems that ensure that these requirements are met.

However, the past decade has seen a 125% growth in the value of the organic food market, with the amount of land used for organic farming growing at around 400,000 hectares per year. The European Commission has now recognized that the current rules need to be updated to support the long term development of organic production in the EU.   One of the key aims of the new regulations will be to ensure that the EU organic logo offers consumers the same guarantee of quality across Europe, including in respect of products imported from outside the EU.

The new rules will:

  • Create an EU-wide set of rules for all organic producers and products. Any necessary exceptions will be limited in time, regularly assessed and applied to all producers to ensure fair treatment.
    Apply equally to non-EU farmers who export their goods to the EU, phasing out the 60+ different “equivalence” standards currently applying to imported organic foods and levelling the playing field between EU and non-EU producers.
  • Enable farmers to apply for group certification for their products, thereby reducing costs and making it easier to join the organic scheme.
  • Apply to new products like salt, cork and essential oils and enable further products to be added in response to consumer demand.
  • Allow national authorities the discretion to reduce controls and inspections on farms from every year to every two years for producers with no record of non-compliance after three consecutive controls.
  • Reinforce the rules on precautionary measures to avoid accidental contamination by pesticides, giving consumers confidence that no pesticides have been used in the production of organic foods.

Following the European Parliament’s first reading, the proposed regulations will come into force on 1 January 2021, repealing Council Regulation (EC) 834/3007.

Please see here for more information on the new proposals.

On November 16, 2017, the Food and Drug Administration (FDA or the agency) issued a federal register notice soliciting comments on its Draft Guidance for Industry, “Best Practices for Convening a GRAS Panel.”

The Draft Guidance is intended for persons responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (FFDCA) when that person convenes a panel of experts (GRAS panel) to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human or animal food.

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The UK tax authority HM Revenue and Customs (HMRC) has published draft Regulations setting out further details on the new UK ‘Soft Drinks Industry Levy’, which will apply from 6 April 2018.

The new levy applies to all soft drinks packaged in or imported to the UK that contain added sugar and at least 5 grams of sugar in total (both naturally occurring and added sugar) per 100ml of prepared drink (“chargeable drinks”). A levy of 18p per liter will apply, rising to 24p per liter for chargeable drinks containing 8 grams or more of sugar per 100ml.

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The U.S. Food and Drug Administration (“FDA”) recently issued a guidance document entitled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for
Human Food and Animal Food: Guidance for Industry.” This guidance is directed toward participants in “co-manufacturing” agreements in which a brand owner arranges for a second party
(the “co-manufacturer”) to manufacture food on its behalf and, as explained below, will affect contracts between brand owners and co-manufacturers, and brand owners and suppliers.

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The UK Food Standards Agency (FSA) is consulting on its proposals to amend the Feed Law Code of Practice and Practice Guidance. The Code and Guidance have to be taken into account by local authorities when enforcing feed law requirements in England (there are separate documents for Wales, Scotland and Northern Ireland).

The FSA is developing an innovative “whole system strategy” to feed law control and enforcement. The proposed amendments to the Code and Guidance aim to improve consistency of enforcement and reduce the regulatory burden for feed businesses, while maintaining a high level of public and animal protection.

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FDA is continuing to release resources intended to assist industry with implementation of the FDA Food Safety Modernization Act (FSMA). This post discusses four such documents that were released recently. First, FDA released Draft Guidance explaining the meaning of the phrase “solely engaged,” which is used in the regulations to establish several exemptions from the Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) rules. Second, FDA finalized its Guidance on current Good Manufacturing Practice (cGMP) requirements for animal food. Third, FDA developed a training program for carriers who are subject to the Sanitary Food Transportation rule. Finally, FDA released a new web page that lists compliance dates for rules that form the foundation of FSMA.

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The European Commission has published a draft implementing Regulation setting out the proposed official EU list of authorized novel foods.

A ‘novel food’ is a food or ingredient that has not been consumed to a significant degree in the EU prior to 15 May 1997. These include products traditionally eaten outside the EU prior to this date, such as chia seeds, argan oil and noni fruit juice, as well as foods produced using innovative processes, such as UV-treated mushrooms.

Currently, food manufacturers looking to use a novel food or ingredient in their products have to obtain prior authorisation from the first country in the EU in which the food/ingredient will be marketed. That authorization applies across the EU but is personal to the applicant, so other companies wishing to use the same food/ingredient have to apply for a separate authorization.

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This post originally appeared on Hogan Lovells Focus on Regulation.